-

March 1st, 2012

Post-Exposure Prophylaxis, the World’s Most Outdated HIV Guidelines, and What To Do About Them

Every time I cover HIV prevention in a lecture, it’s always kind of embarrassing to cite the “official” post-exposure prophylaxis (PEP) guidelines, which are here (non-occupational) and here (occupational).

That’s right, they were last updated in 2005, the year of Hurricane Katrina.

Yes — more than six years ago. The alternative choices seem particularly curious (read: don’t do it) today — indinavir/ritonavir or efavirenz for PEP? You’ve got to be kidding me.

Because here’s a short list of what’s happened since then related to the HIV prevention front:

  • HPTN 052
  • An HIV vaccine study that, marginal efficacy aside, at least gave us a sense of “community risk” in a low-moderate prevalence area
  • iPrEx
  • Landmark studies in perinatal prevention, such as this one
  • That great wave of HIV drug development, which included darunavir, maraviroc, raltegravir, and etravirine

No, there’s not been much new on occupational risk of HIV acquisition, which fortunately remains incredibly rare –and has always been a relatively data-free zone. (For the record, this is pretty much it here.)

So what’s an ID/HIV specialist to do?

I’ve been told that the next round of PEP guidelines is in development, but frankly the existing guidelines have been out of date for so long that something/anything has to be done.

Hence I welcome the imminent publication of this paper on the use of tenofovir/FTC and raltegravir for non-occupational post-exposure prophylaxis.

Yes, the study is small, and there’s no control group; furthermore, given the rarity of transmission, it can’t really estimate the preventive efficacy of this intervention — we’ll probably never have that.

But it provides at least some support behind what we’ve been doing now for several months, which is frequently replacing lopinavir/r with raltegravir — leading to much better tolerability of the PEP regimen.

And our hospital is about to make it official. From my colleague Sigal Yawetz, who heads up our PEP program, comes the following:

First line empiric therapy, not pregnant, no renal problems: tenofovir/FTC, raltegravir

First line therapy, pregnant (or breast feeding, continues to breast feed though not recommended): zidovudine/3TC, lopinavir/r

First line therapy, abnormal renal function: zidovudine/3TC, raltegravir

For any exposure to known infected person: ART to be selected by HIV expert

There — PEP Guidelines updated!

16 Responses to “Post-Exposure Prophylaxis, the World’s Most Outdated HIV Guidelines, and What To Do About Them”

  1. Lynora Saxinger says:

    AGREE!!! PEP is in the Dark Ages, and rather frustrating. Very please to see the groupthink has been going in the same direction (I’m at a Canadian tertiary hospital with an HIV population in care of maybe 1600 ish). Raltegravir is friendlier to take, and the concepy of inhibiting integration is particularly attractive in PEP. Thanks for this post!

  2. Rudy Zimmer says:

    Thank you for the update :-)

    I have been asking the CDC on a 2 monthly basis about the 2011 … now 2012 update of the 2005 occupational and non-occupational PEP guidelines, and they continue to tell me that they are still in development and nothing can be divulged until approved by their process, which appears to be into 2013?

    Since Canada has no national guidelines, we rely on the CDC guidelines, but I have now gone to surfing the world for various guidelines as well as the literature, and your colleague’s suggestions seem reasonable.

    I might add that darunavir boosted with ritonavir has also been successfully used in small groups as expanded therapy with tenofovir/FTC in recent HIV PEP and nPEP with far fewer side effects than using lopinavir boosted with ritonavir.

    Your opinion on this matter is likely shared by many of us providing HIV PEP on a regular basis.

  3. Lenny Berkowitz says:

    Thanks for this succinct review of this important subject. If you think the CDC guidelines are obsolete, check out the New York AIDS Institute guidelines at

    http://www.hivguidelines.org/clinical-guidelines/post-exposure-prophylaxis/recommendations-for-hiv-post-exposure-prophylaxis-pep/

    Although updated in January 2008 they still recommend zidovudine/lamivudine plus tenofovir, or alternatively zidovudine plus tenofovir/emtricitabine. Tolerability among exposed staff has always been very poor.

  4. Buck Pridgen says:

    Oh Horrors!!!! How can anyone in Canada practice cutting
    edge medicine without National Guidelines/Standards!!!

    Oops! Faux pas. Look inward, United States.

  5. AW says:

    5 days ago, while putting IJ for acute dialysis for known HIV pt for ethylene glycol intoxication, with known high viral load (>40,000/ml) I had an accidental needle stick while doing suture. I was placed on 3 anti-HIV drugs same day PM by local inf. dis. specialist. I was told to take it for 4 weeks. He checked with doc following the patient and pt was suppressed with the medications I was prescribed, but chose to stop his therapy.

    1. Is there anything else I should do?

    2. What is my “real” chance of sero-conversion?

    Any help would be appreciated,

    AW

    waland1@excite.com

  6. Paul Sax says:

    Thanks to everyone for their supportive comments! AW, I’d follow the advice of your local ID doctor, and see guidelines for further info about risk. The management may be outdated, but the data on risk are generally still sound.

    Paul

  7. Jennifer McCarthy says:

    Six months ago our institution switched from combivir/kaletra for PEP to Truvada/Darunavir. We are seeing much greater adherence to the PEP regimen and far fewer side effects.

  8. Rod Gordon says:

    When it comes to post-exposure prophylaxis, I’m not sure I understand the need to distinguish between occupational vs non-occupational exposure, when it comes to treatment options.

    If you have been exposed to a significant risk for contracting HIV, it would seem you would just want to use the most effective, best tolerated treatment.

    Do you agree? Do you think there should be separate guidelines, with same/similar treatments?

    Just curious to know whether to push for this change at our rural hospital in a remote part of Alaska. RG

  9. Paul Sax says:

    Rod, I agree — makes little sense to have different regimens for these exposures. Risk assessment, of course, will be different.
    Paul

  10. Debra Benator says:

    Paul, thank you – your comments are great and nice to see literature! Equally surprised at the absence of formal “guidance”. We published case reports in 2008 (Siegel, MO, Kan, VL, Benator, DA. Raltegravir for postexposure prophylaxis following occupational exposure to HIV. AIDS 2008; 22:2552)
    and have taken this approach when insufficiently confident in Truvada alone.

  11. Gert van Zyl says:

    I fully agree – guidelines are completely outdated. Due to the poor tolerability of an AZT, 3TC combination tablet, we want to encourage the introduction of TDF+FTC/3TC in South Africa(with LPV/r for high risk cases; as we do not have access to Raltegravir in the public health setting)- but a lack of updated international practice guidelines would make my campaign a difficult one.

  12. J. Keller says:

    Thank you Dr. Sax for this much needed corrective/intervention! I’m wondering if you’ve given any thought to the 2005 CDC post-PEP testing guidelines, which seem equally archaic?

  13. Paul Sax says:

    I’m wondering if you’ve given any thought to the 2005 CDC post-PEP testing guidelines, which seem equally archaic?

    Agree entirely. Am hopeful we’ll get some new guidelines soon. (I’m an optimist.)

    Paul

  14. Pep Guy says:

    Please keep something in mind. I was like you when i was put on PEP – demanding to know why I had to take “inferior” medications from over 10 years ago when there were much more intelligent drugs available. The issue on the table I think is safety. The more advanced HIV meds have become, the more complex they have become, and the less we know about their safety profile. If you’ve got an established safety percentage based on 10+ years as well as an effectiveness percentage on the same time frame, it seems more intelligent to me to wait untl you’ve gathered enough data on the newer stuff, before you begin recommending them. These drugs are for *HEALTHY* people. Therefor the risk to their bodies is *HUGE*. I took PEP in Feb 2012, and have been unwell ever since. I am now 8 months post PEP and have physical and health problems with no explanation or diagnosis that reek of neurodegenerative and motor neuron disease. Mitochondrial Toxicity, etc. If there is a delay in deciding which of the many toxic chemicals to pour into healthy people’s bodies, I respect that process immensely, even if I am fully aware that the CDC is insanely behind on countless updates for countless health issues.

  15. horace says:

    Why is using efavirenz in pep wrong. I dont quite understand, because atripla is an effective ARV regimen why would it be effective as PEP

  16. Mike says:

    http://www.health.alberta.ca/documents/PEP-Guidelines-2013.pdf

    http://www.ncbi.nlm.nih.gov/pubmed/22267017

    2months of searching and though the HIV protocols seem to have new life as of mid Feb, PEP protocols remain a mystery

Leave a Reply

Note: This is a moderated forum. By clicking on the "Submit Comment" button below, you agree to abide by the NEJM Journal Watch Terms of Use.

HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Editor-in-Chief

NEJM Journal Watch HIV/Aids Clinical Care

Biography | Disclosures | Summaries

Learn more about HIV and ID Observations.